Informing patients and the public about clinical trials and their results

2:15 PM - 2:55 PM

This presentation aims to provide an overview about different lay language documents to inform patients and the public about clinical trials and their results. Communicating safety results in lay language documents is challenging because of the multi-dimensional nature of safety data. The translation of MedDRA terms into lay language is an additional hurdle.

Beyond regulatory lay language documents, such as brief summaries, lay summaries, and Informed Consent Forms, there are further ways to engage with patients, study participants, and the public. Formats such as graphics, comics or videos are new ways to engage with these audiences. This presentation highlights the benefits of using these tools when communicating about a particular trial. Furthermore, it addresses the limitations and challenges of developing such content from a sponsor’s perspective. Case studies are used to provide insights into the development steps and key considerations.